Actively Recruiting

Age: 18Years - 55Years
FEMALE
NCT05500118

Establishment of a Decision Aid Tool for Asymptomatic Small Leiomyoma and Analysis of Influencing Factors for Clinical Decision-making Using HIFU

Led by Shenzhen Maternity & Child Healthcare Hospital · Updated on 2022-08-12

120

Participants Needed

1

Research Sites

260 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

With the younger patients diagnosed with asymptomatic leiomyoma, delay in the reproductive age of women, the advancement of medical technology, and the rapid development of treatment methods, there are many choices between gynecologists, gynecologists and patients because of experience and knowledge. It is not easy to make the most favorable choice for patients. This study is mainly led by a committee composed of designers, doctors, nurses and patients, and based on clinical guidelines and evidence-based medicine. Co-operating with patients with asymptomatic small leiomyoma, we want to find the influencing factors of clinical decision-making, and to establish a patient decision aid tool. We use prospective trial to verify that the use of this tool can improve patients' decision-making efficacy and further improve patient-reported outcomes.

CONDITIONS

Official Title

Establishment of a Decision Aid Tool for Asymptomatic Small Leiomyoma and Analysis of Influencing Factors for Clinical Decision-making Using HIFU

Who Can Participate

Age: 18Years - 55Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Female patients aged 18 to 55 years
  • Diagnosed with leiomyoma by ultrasound or MRI with no clinical symptoms
  • Maximum diameter of a single leiomyoma less than 5 cm and no more than 10 leiomyomas by MRI
  • No contraindications for sedation and analgesia
  • Patients and their families agree to participate and can attend follow-up visits on time
Not Eligible

You will not qualify if you...

  • History of myomectomy (transabdominal, laparoscopic, hysteroscopy, etc.)
  • History of connective tissue diseases or abdominal radiotherapy
  • Pregnancy, acute reproductive tract inflammation, or other gynecological benign or malignant diseases such as endometriosis or ovarian tumors
  • Leiomyoma diameter 5 cm or larger
  • Suspected malignant tumor like sarcoma
  • Language communication barriers preventing cooperation with sedation and analgesia
  • Abdominal scarring causing significant sound attenuation on ultrasound (more than 10 mm)

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Shenzhen Maternal and Child Health Hospital

Shenzhen, Guangdong, China, 518000

Actively Recruiting

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Research Team

Y

Yu Dai, Associate Professor

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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